N.A

Trade name

N.A

UDI-DI code

06971996068166

Basic UDI-DI

697199606005P9

Reference / catalog number

HY-KW-001

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 400–420 MU50
• 130–150 MU50

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z120602PHYSIOTHERAPY EQUIPMENT

7 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW258

  EUDAMED did not publish a description for this code.
• CW999

  Contraindication: • Can't use for people who have diabetes, poor circulation or heart disease. • Can’t use for people with rheumatoid arthritis. • Can't use together with other forms of therapeutic heat, including electric heating. • Can't use of unhealthy, damaged or broken skin, or sensitive skin. • Can't use for people unable to remove the product, including children, infants, pets, pregnant women, and some elderly. • Can't use for children 12 and under. • If your doctor does not recommend its use for you or your condition.
• CW999

  Warning: • For single use only. Do not reuse and Do not use while sleeping. • If the heat pad material is damaged or tom. • With medicated lotions, creams or ointments. • On areas of bruising or swelling that have occurred within 48 hours. • If you are not capable of applying and removing the wrap by yourself. • If you are bedridden or prone to skin ulcers. • On areas of the body where you can’t feel heat, and use with caution in elder aged 65 and over • Be more careful to use for older people or the people whose skin acceptance for heat is lower • Check skin frequently for signs of burns or blisters, please stop use if you found • Stop use and ask a doctor if you experience any discomfort, burning, swelling, rash or other changes in your skin • To lower the risk of low-temperature burn, pls do not place extra stress pressure • Immediately stop use and ask a doctor if you experience any discomfort, burning, swelling, rash or other changes in your skin.

No certificate specifically references this device's Basic UDI-DI.